Government of Canada Passes “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) – Modernized Patient Safety Laws for Drugs and Medical Devices

On December 6, 2013 it was announced that a new patient safety legislation would be introduced known as the “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)”. The law is named after Vanessa Young, the daughter of MP Terence Young, who died of a heart attack after taking an unsafe prescription drug…[Read our Original Blog Post Regarding the Announcement of Vanessa’s Law Here]
Since the announcement in 2013 the law has passed and marks a major milestone in Canada’s drug safety history. This Act will Continue reading

FDA releases draft guidance to outline standardized electronic study data format

When finalized, the guidance for industry “Providing Regulatory Submissions in Electronic Format – Standardized Study Data” will specify and implement electronic submission requirements for study data contained in NDAs, ANDAs, certain BLAs, and certain INDs. This guidance’s requirements will also be applied to Continue reading

FDA Recommends Tighter Restrictions on Most Popular Prescription Drug Category in the US

Access to opioid-based painkiller medications has been the topic of debate for years – some saying it should be more accessible, others arguing that it should be restricted. With the recent focus on the US opioid epidemic, individual states, industry and the FDA have been moving to increase prescriber education, create abuse resistant products and tighten regulations around opioid based drugs.

On 24 October 2013, the FDA announced it will Continue reading